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Dexamethasone-Eluting Stent in Acute Coronary Syndrome to Prevent Restenosis

This study has been completed.
Sponsor:
Information provided by:
Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00190099
First received: September 11, 2005
Last updated: November 17, 2005
Last verified: December 2004
  Purpose

The major obstacle of the long- termed success of percutaneous coronary intervention (PCI) is the restenosis. Restenosis results from complex pathophysiological response of the vascular tissue to the balloon injury. In the pre-stent era, 80% of it was attributed to vascular recoil. However, by way of the mechanical support of metallic stent, recoil is no more the major reason of restenosis. About 80 % of In-stent restenosis resulted from intimal hyperplasia.

The mechanism of the Intra-stent restenosis included 4 stages. First stage comprised the first 3 days after balloon injury, when the inflammatory reaction is most severe throughout the course. At that time, anti-inflammatory drug as steroid wuold be helpful to prevent the course of restenosis. Until the end of the third week, smooth muscle cells migrate and then proliferate in the second and the third stage, and the key effort to prevent restenosis right now is inhibition of cell cycle. Intravascular radiotherapy (so called Brachytherapy) and stent-based drug elution target upon them. Among them, rapamycin and paclitaxel proved to be effective both in animal and human experience. The last stage is re-epithelization, estrogen could promote the process and was considered to be effective in this stage.

Stent-based elution of corticosteroid, despite of its feasibility and safety, was not as effective as other anti-proliferation agent ( eg. Rapamycin etc). The major reason might be the patient group with coronary artery disease is a heterogenous one.

We believe if we applied corticosteroid over the patient with elevated inflammatory parameters, i.e. acute coronary syndrome (ACS) the effect of anti-restenosis would be obvious.

In this study, by a special-designed, phosphorylcholine-coated stent, dexamethasone could be readily absorbed and then gradually released locally even 4 weeks after deployment.

We expected a reduction of In-stent restenosis in ACS patient by the method with no or few systemic adverse effect of steroid; and angiographic follow-up as well as intra-vascular ultrasound assessment would be performed according to pur protocol.


Condition Intervention Phase
Vessel Restenosis
Device: Dexamethasone-Eluting Stent
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Far Eastern Memorial Hospital:

Estimated Enrollment: 40
Study Start Date: January 2003
Estimated Study Completion Date: December 2003
Detailed Description:

The major obstacle of the long- termed success of percutaneous coronary intervention (PCI) is the restenosis. Restenosis results from complex pathopysiological response of the vascular tissue to the balloon injury. In the pre-stent era, 80% of it was attributed to vascular recoil. However, by way of the mechanical support of metallic stent, recoil is no more the major reason of restenosis. About 80 % of In-stent restenosis resulted from intimal hyperplasia.

The mechanism of the Intra-stent restenosis included 4 stages. First stage comprised the first 3 days after balloon injury, when the inflammatory reaction is most severe throughout the course. At that time, anti-inflammatory drug as steroid would be helpful to prevent the course of restenosis. Until the end of the third week, smooth muscle cells migrate and then proliferate in the second and the third stage, and the key effort to prevent restenosis right now is inhibition of cell cycle. Intravascular radiotherapy (so called Brachytherapy) and stent-based drug elution target upon them. Among them, rapamycin and paclitaxel proved to be effective both in animal and human experience. The last stage is re-epithelization, estrogen could promote the process and was considered to be effective in this stage.

Stent-based elution of corticosteroid, despite of its feasibility and safety, was not as effective as other anti-proliferation agent ( eg. Rapamycin etc). The major reason might be the patient group with coronary artery disease is a heterogenous one.

We believe if we applied corticosteroid over the patient with elevated inflammatory parameters, i.e. acute coronary syndrome (ACS) the effect of anti-restenosis would be obvious.

In this study, by a special-designed, phosphorylcholine-coated stent, dexamethasone could be readily absorbed and then gradually released locally even 4 weeks after deployment.

We expected a reduction of In-stent restenosis in ACS patient by the method with no or few systemic adverse effect of steroid; and angiographic follow-up as well as intra-vascular ultrasound assessment would be performed according to pur protocol.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ACS patient

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00190099

Sponsors and Collaborators
Far Eastern Memorial Hospital
Investigators
Principal Investigator: A H Li, MD Far Eastern Memorial Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00190099     History of Changes
Other Study ID Numbers: FEMH-93005
Study First Received: September 11, 2005
Last Updated: November 17, 2005
Health Authority: Taiwan: Department of Health

Keywords provided by Far Eastern Memorial Hospital:
In-stent restenosis,
Drug eluting stent,
dexamethasone,
Acute coronary syndrome

Additional relevant MeSH terms:
Acute Coronary Syndrome
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Heart Diseases
Myocardial Ischemia
Pain
Signs and Symptoms
Vascular Diseases
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014